Job Description: Clinical Trial Site Activation Specialist (Study Start-Up)
Our 3 Core Values
- Intelligence
- Integrity
- Initiative
Toronto/Hybrid
What You’ll Do
The Site Activation Specialist serves as the primary point of contact for investigative sites, project management, and cross-functional teams during the start-up phase of a clinical trial. You will drive the operational path from site identification through activation, managing regulatory and ethics committee submissions, budget negotiations, and essential document collection to ensure on-time study launches.
Key Responsibilities
- Site Start-Up & Coordination: Coordinate and track the end-to-end start-up and activation process for assigned clinical trial sites in accordance with project timelines and quality standards.
- Regulatory & Ethics Submissions: Prepare, review, submit, and track regulatory and Institutional Review Board (IRB) / Ethics Committee (EC) documents and applications (e.g., FDA 1572, Informed Consent Form local customization).
- Contracts & Budgets: Facilitate and support clinical trial agreement (CTA) and budget negotiations between sponsors/CROs and investigative sites.
- Document Management: Collect, review for completeness/accuracy, and process essential regulatory and financial documents into the Trial Master File (TMF) or CTMS.
- Stakeholder Communication: Maintain regular, proactive communication with investigative site personnel, clinical research associates (CRAs), and project leadership to resolve bottlenecks and escalate risks.
- Timeline Tracking: Monitor startup metrics and update internal tracking systems and dashboards to ensure accurate forecasting and alignment with First Patient In (FPI) targets.
Qualifications & Skills
- Education: Bachelor’s degree in a life sciences field, healthcare, or equivalent relevant professional experience.
- Experience: 2-5+ years of clinical research experience, with a specific focus on study start-up, site activation, or regulatory submissions within a CRO or pharma environment.
- Knowledge Base: Solid understanding of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements.
- Technical Skills: Familiarity with Clinical Trial Management Systems (CTMS), Electronic Trial Master Files (eTMF), and regulatory platforms.
- Soft Skills: Exceptional organizational skills, multi-tasking abilities across multiple concurrent studies, high attention to detail, and strong cross-functional communication.
About Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a global leader in relapsed/refractory AL Amyloidosis. AL Amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a “digital filter” that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a registrational design. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA. Learn more at www.immixbio.com and www.BeProactiveInAL.com.
